The European Commission proposed, on Friday 17 December, as it had announced in the autumn, to review EU rules to ensure Northern Ireland has fair access to medicines. This legislative initiative, which also covers Cyprus, Malta and Ireland, gives substance to discussions that have been ongoing for several months between the Commission and the UK government on how to facilitate the arrival of medicines in Northern Ireland from Great Britain under the Ireland/Northern Ireland Protocol.
In particular, the Commission had indicated in a package of proposals presented on 13 October (see EUROPE 12811/14) that it needed to revise the Union’s provisions on medicines to take these talks forward. This is what it did on 17 December, presenting both at the same time: - a Directive amending Directives 2001/20/EC and 2001/83/EC (as regards exemptions from certain obligations in respect of certain medicines for human use made available in the United Kingdom in respect of Northern Ireland and Cyprus, Ireland and Malta); - a delegated regulation amending delegated regulation (EU) 2016/161 as regards the derogation from the obligation of wholesalers to downgrade the unique identifier of medicines exported to the United Kingdom; - a regulation on the exemption of innovative medicines made available in the United Kingdom in respect of Northern Ireland, Cyprus, Ireland and Malta.
The proposal aims to ensure the long-term continuity of supply of medicines to Northern Ireland from Great Britain while establishing specific conditions for medicines authorised by the UK not to enter the Single Market.
“I am convinced that the issue of medicines shows that the EU and the UK can work together for stability and prosperity of all communities in Northern Ireland. It also shows that the protocol has the flexibility to work on the ground”, commented Commission Vice-President Maroš Šefčovič on the same day, wishing to “carry this momentum into the other areas of discussion” covered by the 13 October package, such as customs or phytosanitary controls.
Among other things, the proposals will allow generic medicines to be authorised under UK national procedures and all regulatory functions to remain in the UK, if they are currently located there. For medicines brought into Northern Ireland from the rest of the UK, batch testing does not need to be repeated if it has already been carried out in Great Britain or the EU and no manufacturing authorisation or import licences are needed for medicines supplied from Great Britain to Northern Ireland, subject to certain conditions.
Malta, Cyprus and Ireland will also benefit from certain derogations for a 3-year period.
Discussions on the Northern Ireland Protocol will resume in early 2022. The differences between the two parties have not yet been resolved, as the Commission would have liked, particularly with regard to the governance of the protocol and the role of the Court of Justice of the EU, which the British government still wants to see evolve.
“Progress has been made, but not as much and not as quickly as we had hoped. The main area where we have made progress is in the supply of medicines to Northern Ireland”, commented David Frost on 17 December.
“A solution is needed on governance”, the minister reiterated, saying it was “not reasonable or fair for disputes between the UK and the EU relating to the Protocol to be settled in the EU Court of Justice”.
“The Court of Justice is not within my negotiating mandate”, the Vice-President reiterated, stressing again that the single market cannot function properly without the Court of Justice. He also urged London to “reciprocate” EU efforts on the Protocol talks.
Link to the proposals: https://bit.ly/3F7e5Eg (Original version in French by Solenn Paulic)